FDA's Draft Guidance on Label Highlights Section

The new guidance includes content and formatting information, and acknowledges where carton and container labels may differ from the Highlights. Comments are due March 20.

The new guidance includes content and formatting information, and acknowledges where carton and container labels may differ from the Highlights. Comments are due March 20.
The new guidance includes content and formatting information, and acknowledges where carton and container labels may differ from the Highlights. Comments are due March 20.

Last month, the FDA released a new draft guidance providing recommendations on completing certain portions of the Highlights section for those developing labels for new drugs and revising labels for existing drugs.

The 39-page document offers guidance on the content and format of the product title and initial US Approval subsections within the Highlights of Prescribing Information (Highlights), with some packaging specifics.

The document’s background section references what is referred to as the physician labeling rule, established in a final rule in 2006, which requires that prescription labeling contain three sections: Highlights, Contents and Full Prescribing Information.

The Highlights section, as the name implies, contains key information needed by physicians and healthcare providers:

  • the drug’s proprietary name

  • nonproprietary name

  • any appropriatedescriptors

  • dosage form

  • route of administration

  • the controlled substance symbol, if applicable

Packaging implications

This new draft guidance includes examples for the requirements listed above, as well as information on how to address drug products with special nomenclature, such as infusion solutions and co-packaged drug products.

It also offers implications for container and carton labeling, acknowledging that there may be differences between the product title in Highlights and the container and carton labeling:

  • Name: The proprietary name should be in uppercase in Highlights, even if it is presented differently on the container or carton labeling.

  • Symbols: The placement of the elements of the product title (e.g., controlled substance symbol) may occasionally vary between the container and carton labeling and the product title in Highlights.

  • Formatting: All elements of a product title in Highlights should appear on one line as space permits, but dosage form and route of administration information can be presented beneath the drug or biological product name on container and carton labeling.

  • Abbreviations: Abbreviations for salts (e.g., HCl for hydrochloride) are appropriate for use on container and carton labeling provided their use is consistent with USP’s labeling requirements.

  • Product strength: The strength of the drug product is not typically in the product title in Highlights, but appears elsewhere in the prescribing information and on container and carton labeling.

  • Route of administration: Information may differ between the container and carton labeling and the product title in Highlights. The guidance offers the following examples:

    • When important for patient safety, the word “only” may appear with the route of administration (e.g., For topical use only) on the container and carton labeling, and elsewhere in the prescribing information, but should not be in the product title.

    • Methods of intravenous administration (e.g., intravenous infusion) may be on the container and carton labeling, but such terms should not be in the product title.

The FDA is accepting comments on the guidance until Mar. 20, 2018. Comments can be submitted at the Federal Register.

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